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NCT03590574 · ADVERSE EVENTS

Adverse events

Phase I/II Study Evaluating AUTO4 in Patients With T Cell Receptor Beta Constant (TRBC)1 Positive T Cell Lymphoma · Source last updated 2026-03-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
From Day -6 up to 24 months After Day 60, only the following were collected: SAEs and treatment-related non-serious AEs; AEs of special interest; AEs related to a study procedure.
Other-event reporting threshold
0%

Only AEs/SAEs related to study procedures were collected after admission for lymphodepletion chemotherapy (Day -6 \[-1 day\]). AEs related to intervening/bridging non-study related anti-cancer therapy administered prior to pre-conditioning or AEs associated with disease progression during the same period were not reported as AEs, but were recorded as an update to the patient's medical history.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I Dose Escalation - Cohort 1

Patients received 25x10\^6 RQR8/aTRBC1 CAR T-positive cells

2 / 33 / 31 / 3
Phase I Dose Escalation - Cohort 2

Patients received 75x10\^6 RQR8/aTRBC1 CAR T-positive cells

1 / 22 / 21 / 2
Phase I Dose Escalation - Cohort 3

Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells

0 / 11 / 10 / 1
Phase I Dose Escalation - Cohort 4

Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells

2 / 44 / 41 / 4
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3

Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells

0 / 11 / 10 / 1
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4

Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells

2 / 32 / 32 / 3
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5

Patients received 900x10\^6 RQR8/aTRBC1 CAR T-positive cells

1 / 11 / 11 / 1
Not Treated

Patients leukapheresed but not administered

1 / 50 / 52 / 5

Group identifiers: EG000: Phase I Dose Escalation - Cohort 1 · EG001: Phase I Dose Escalation - Cohort 2 · EG002: Phase I Dose Escalation - Cohort 3 · EG003: Phase I Dose Escalation - Cohort 4 · EG004: Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 · EG005: Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 · EG006: Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 · EG007: Not Treated

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Immune thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Lymph node pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Atrial fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Ascites
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Gastric haemorrhage
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Fatigue
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Cytokine release syndrome
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Epstein-Barr virus infection reactivation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Infection

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Febrile neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Immune thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Lymph node pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Atrial fibrillation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Palpitations
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Dry eye
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Diarrhoea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Nausea
Complete source fields
description
Only AEs/SAEs related to study procedures were collected after admission for lymphodepletion chemotherapy (Day -6 \[-1 day\]). AEs related to intervening/bridging non-study related anti-cancer therapy administered prior to pre-conditioning or AEs associated with disease progression during the same period were not reported as AEs, but were recorded as an update to the patient's medical history.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Patients received 25x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Phase I Dose Escalation - Cohort 1
  2. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    Patients received 75x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Phase I Dose Escalation - Cohort 2
  3. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Phase I Dose Escalation - Cohort 3
  4. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Phase I Dose Escalation - Cohort 4
  5. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    EG004
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3
  6. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    EG005
    other Num Affected
    2
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4
  7. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Patients received 900x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    EG006
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5
  8. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    Patients leukapheresed but not administered
    id
    EG007
    other Num Affected
    0
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Not Treated
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Febrile neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Immune thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Lymph node pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Atrial fibrillation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Palpitations
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Dry eye
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Diarrhoea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Nausea
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Immune thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Lymph node pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Atrial fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Ascites
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Gastric haemorrhage
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Fatigue
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Cytokine release syndrome
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Epstein-Barr virus infection reactivation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    term
    Infection
time Frame
From Day -6 up to 24 months After Day 60, only the following were collected: SAEs and treatment-related non-serious AEs; AEs of special interest; AEs related to a study procedure.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice